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WO2019101855A1 - Détermination de vitesse d'onde pulsatile - Google Patents

Détermination de vitesse d'onde pulsatile Download PDF

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Publication number
WO2019101855A1
WO2019101855A1 PCT/EP2018/082216 EP2018082216W WO2019101855A1 WO 2019101855 A1 WO2019101855 A1 WO 2019101855A1 EP 2018082216 W EP2018082216 W EP 2018082216W WO 2019101855 A1 WO2019101855 A1 WO 2019101855A1
Authority
WO
WIPO (PCT)
Prior art keywords
pulse
actuator
sensor
vessel
pulse wave
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/EP2018/082216
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English (en)
Inventor
Achim Rudolf HILGERS
Cornelis Petrus HENDRIKS
Marjolein Irene VAN LIESHOUT
Gerhardus Wilhelmus Lucassen
Eduard Gerard Marie Pelssers
Mark Thomas Johnson
Daan Anton VAN DEN ENDE
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Koninklijke Philips NV
Original Assignee
Koninklijke Philips NV
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Filing date
Publication date
Application filed by Koninklijke Philips NV filed Critical Koninklijke Philips NV
Priority to CN201880075939.0A priority Critical patent/CN111372512A/zh
Priority to EP18804010.9A priority patent/EP3713483B1/fr
Priority to US16/766,078 priority patent/US20200345246A1/en
Priority to JP2020528135A priority patent/JP2021504000A/ja
Publication of WO2019101855A1 publication Critical patent/WO2019101855A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/02108—Measuring pressure in heart or blood vessels from analysis of pulse wave characteristics
    • A61B5/02125—Measuring pressure in heart or blood vessels from analysis of pulse wave characteristics of pulse wave propagation time
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/02007—Evaluating blood vessel condition, e.g. elasticity, compliance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/02133—Measuring pressure in heart or blood vessels by using induced vibration of the blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/0215—Measuring pressure in heart or blood vessels by means inserted into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
    • A61B5/6876—Blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0219—Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0247—Pressure sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0261—Strain gauges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/0215—Measuring pressure in heart or blood vessels by means inserted into the body
    • A61B5/02156—Calibration means

Definitions

  • This invention relates to the determination of pulse wave velocity, for example for blood pressure monitoring.
  • Vital signs monitor systems help to reduce treatment costs by disease prevention and enhance the quality of life. They may provide improved physiological data for physicians to analyze when attempting to diagnose a subject’s general health condition.
  • Vital signs monitoring typically includes monitoring one or more of the following physical parameters: heart rate, blood pressure, respiratory rate and core body temperature.
  • the condition of the hypertensive patients can be improved by lifestyle changes, healthy dietary choices and medication. Particularly for high risk patients, continuous 24 hour blood pressure monitoring is very important and there is obviously a desire for systems which do not impede ordinary daily life activities.
  • Blood pressure is usually measured as two readings: systolic and diastolic pressure.
  • Systolic pressure occurs in the arteries during the maximal contraction of the left ventricle of the heart.
  • Diastolic pressure refers to the pressure in arteries when the heart muscle is resting between beats and refilling with blood.
  • Normal blood pressure is considered to be 120/80 mmHg.
  • a person is considered to be hypertensive when the blood pressure is above 140/90 mmHg, and two stages of hypertension may be defined for increasing blood pressure levels, with hypotensive crisis defined when blood pressure reaches 180/110 mmHg. Note that for conversion of these values to metric equivalents, 760.0 mmHg is equal to 101.325 kPa.
  • the gold standard is by catheterization.
  • a strain gauge in fluid is placed in direct contact with blood at any artery site. This method is only used when accurate continuous blood pressure monitoring is required in dynamic (clinical) circumstances. It is most commonly used in intensive care medicine and anesthesia to monitor blood pressure in real time.
  • oscillometry is a popular automatic method to measure blood pressure.
  • the method uses a cuff with integrated pressure sensor.
  • the cuff usually inflates and deflates at regular time intervals to measure the subject’s blood pressure. This often has a huge negative impact on the sleep quality.
  • PWV pulse wave velocity
  • PTT pulse transit time
  • the PWV can be translated to a blood pressure estimate by means of a calibration step. Often the Moens-Korteweg equation is applied which describes the relationship between blood pressure and PWV.
  • the blood pressure can be directly inferred from PTT by means of a calibration function.
  • Other methods to measure blood pressure include techniques based on auscultation, tonometry, ultrasonic measurements, and pulse wave morphology.
  • Implantable devices enable unobtrusive and long term monitoring of patients with chronic diseases such as heart failure, peripheral artery disease or hypertension.
  • the purpose of monitoring is to provide reassurance or early warning indicators, but also to reduce or in general to control medication.
  • Cardiovascular implantable devices which are already available, or are being developed, are for instance blood pressure sensors (Cardiomems), restenosis sensors (iStent), or controlled drug delivery implants based on e.g. a micro- peristaltic pump (MPS microsystems).
  • Cardiomems blood pressure sensors
  • iStent restenosis sensors
  • MPS microsystems micro- peristaltic pump
  • measurements of the condition of a vessel for example based on the propagation and reflection of a pressure wave.
  • a system for determining a pulse wave velocity includes a body insertable device.
  • Body insertable devices can include those that are only temporarily inserted in the body such as during treatment of a patient in e.g. surgery or for a short recovery period of e.g. a few hours or days. However they particularly include or are the same as implantable devices that may remain in the body for longer periods of time such as e.g. weeks or months or years.
  • This system includes an actuator capable of creating an artificial pulse through its actuation which pulse is transmitted along a wall of a vessel or organ over a known distance before it is detected by a sensor also included in the system.
  • the pulse is a mechanical pulse, namely a physical movement which thus generates a pressure wave, which may travel in a liquid or (flexible) solid medium.
  • the actuator is preferably driven by an electrical signal although in principle actuation could be performed using another stimulus such as light.
  • the body insertable device can be attached to a vessel (e.g. artery) or implanted in a vessel.
  • the body insertable device may be positioned close by or directly on a (part of a) vessel prone to be covered with plaque or any other vessel (arterial) depositions affecting the vessel (artery) stiffness.
  • an arbitrary artificial pulse wave can be generated in the blood and/or the vessel wall, independent from (and additional to) the heart pulses.
  • the distance between the sensor and the actuator can be assumed to be known very precisely prior to the application and also can be assumed to be stable during operation.
  • the sensor is responsive to pressure or deformation or motion.
  • the generated pulse is very reliable and precise over time, such that no variation of the time interval or pulse amplitude/shape between generation and reception applies. If a variation is detected, either in amplitude, shape or time interval, this may for example be used as an indication of a change in the signal/propagation path, which would be the case e.g. for a stenosis caused by plaque.
  • Analyzing the artificial pulse shape may include analysis of time derivatives (in particular the first and second derivatives) of the received pulse as well as transformations in the frequency domain (using a Fast Fourier Transform, FFT).
  • Sensing of the pulse can comprise sensing of arrival of the pulse by the sensor at the second location. The sensor will sense the pulse and provide a sensor signal based on the pulse. This signal can be analyzed by the controller.
  • the distance between first and second location is preferably 2 cm or more. More preferably it is 4 cm or more and even more preferably it is 6 cm or more. For a somewhat compact system the distance can be less than 25 cm or less than 20 or less than 15 or less than 10 cm.
  • the body insertable device may for example comprise a cuff for implanting around an artery. The actuator is then for compressing or striking the artery to induce a pressure wave.
  • the actuator may be at a point location or it may be around a circumference of the vessel wall.
  • the body insertable device can be one single unit comprising the actuator and the sensor.
  • the body insertable device can also be in the form of a first unit comprising the actuator and a second unit, separate from the first unit, comprising the sensor. This allows the actuator and sensor to be placed further apart, but at the expense of a possible separate insertion of implantation procedure.
  • the system may further comprise a second sensor located with the actuator and a second actuator located with the sensor, thereby to enable a velocity measurement in opposite directions. This may be used to compensate for the blood flow velocity when determining the pulse velocity, and it may enable separate determination of the blood flow velocity.
  • the actuator and the second sensor may be a first multifunctional device and the sensor and second actuator may be a second multifunctional device.
  • devices which can perform sensing and actuation, either simultaneously or time sequentially, may be employed.
  • the actuator is for example adapted to provide a pulse to the vessel wall for travelling along the vessel wall to the sensor or to provide a pulse to the vessel wall for travelling through the vessel contents to the sensor.
  • the controller is capable of receiving the sensor signal and of analyzing the sensor signal. It is capable of determining a pulse wave velocity. It may also be capable of providing for example an indication of vessel wall stiffness and/or blood flow velocity. This may be done based on the analyzed pulse.
  • the controller may be part of the body insertable device, and may be capable of transmitting the analysis results to a receiver remote form the body insertable device. To reduce space in the body insertable device, the controller is preferably remote from the body insertable device.
  • the sensor transmits the sensor signal to the controller which performs the analysis to provide the desired results to a user.
  • the actuator may comprise an electroactive polymer actuator.
  • the same type of device, or even the same actual device, may be used for sensing and actuation. These devices enable soft, silent and low power sensors and actuators in a small form factor and are therefore ideally suited to be embedded into smart implants.
  • the sensor may comprise a pressure sensor, motion sensor or strain gauge.
  • One preferred example is an electroactive polymer pressure or deformation sensor.
  • the disclosure pertains to the use of a system as claimed for determining a pulse wave velocity.
  • the disclosure also provides a method for determining a pulse wave velocity, comprising:
  • the method may further comprise determining an indication of vessel wall stiffness or of blood flow velocity.
  • the disclosure pertains to a computer program (product) comprising computer program code means stored on a computer readable medium or downloadable from a computer network, which program is adapted, when run on a computer, to implement the control steps and optionally the analyzing step of the method.
  • Figure 1 shows a first example of a system for determining a pulse wave velocity
  • Figure 2 shows blood flow and arbitrary pulse propagation may be superposed
  • Figure 3 shows a second example of a system for determining a pulse wave velocity
  • Figure 4 shows an example in which the actuator is part of a first body insertable device and the sensor is part of a second body insertable device;
  • Figure 5 shows a modification in which there is an actuator and a sensor at each end of the implant.
  • Figure 6 shows two levels of vessel blockage controlled by the actuator.
  • the invention provides a system for determining a pulse wave velocity, comprising an body insertable device with an actuator for providing a pulse in the vicinity of a vessel wall and a sensor for sensing arrival of the pulse.
  • a pulse wave velocity is obtained from the time difference between actuation of the actuator and sensing of the pulse.
  • This system is used to create an artificial pulse which is transmitted along a vessel by a known distance before detection by a sensor.
  • the system can be used for investigating a wall of a vessel or organ of a human or animal subject.
  • the system can be used to probe the wall of any organ in a human or animal body.
  • vessels and their walls Important vessels are those of the blood circulatory system such as an artery or aorta. Other vessels can be probed as well. These could include those of the lymphatic system, those of the airways such as bronchia or those of the digestive system, such as the esophagus or gastrointestinal tract.
  • the invention provides a system and method which makes use of the concepts of pulse wave velocity (PWV) and pulse transit time (PTT), which each relate to propagation of the pulse pressure wave along the arterial tree. It is known that PTT and PWV can be used as a predictor of blood pressure.
  • PWV pulse wave velocity
  • PTT pulse transit time
  • PTT is defined as the propagation time of a blood pulse wave to travel a certain distance in an arterial segment.
  • ECG electrocardiography
  • PPG photoplethysmography
  • a known distance can be chosen between actuator and sensor, i.e. between location of generation of the pulse and location of sensing of the pulse.
  • the distance needed may depend on the pulse transmission properties of the tissue in the vicinity of the vessel. For example, assuming a sensor output sample rate of about 10 kHz (should be achievable with a fairly simple controller), which correlates to a sample time interval of 100 microseconds, the distance a pulse wave may travel within an aorta (vessel) is around 700 micrometers, as a pulse wave velocity in such vessel may be around 7 (plus or minus 2) meter s/second. Further assuming a 1 % or better accuracy of measuring this distance, the full distance between location of providing the pulse and sensing of the pulse needs to be 70 mm.
  • a distance range could be larger than 2 cm, larger than 4 cm or larger than 6 cm.
  • a useful range can be between 5 cm and 10 cm, which may correlate with current stent sizes used in surgery. It will be clear that other ranges of distance can be chosen and also that other sampling rates may be chosen. More elaborate discussion of distances also in relation to signal analysis is provided herein below.
  • the distance can be measured form first location (where the actuator provides a pulse) to the second location (where the sensor senses the pulse).
  • the pulse wave velocity is related to the intrinsic elasticity of the arterial wall.
  • PWV is increased in stiffer arteries and, when measured over the aorta, is an independent predictor of cardiovascular morbidity and mortality. Given the predictive power of PWV, identifying strategies that prevent or reduce stiffening may be important in prevention of cardiovascular events.
  • aortic stiffness occurs as a result of atherosclerosis along the aorta. However, there is little or no association between PWV and classical risk factors for atherosclerosis, other than age and blood pressure.
  • PWV does not increase during early stages of atherosclerosis, as measured by intima-media thickness and non-calcified atheroma, but it does increase in the presence of aortic calcification that occurs within advanced atherosclerotic plaque.
  • Age-related broadening of pulse pressure is the major cause of age-related increase in prevalence of hypertension and has been attributed to arterial stiffening.
  • C is a measure of volume change (AV) in response to a change in blood pressure (DR):
  • D Distensibility
  • PWV is calculated by measuring the time taken for a pressure pulse to travel between two set points.
  • carotid and femoral pulse waves are obtained with pressure sensitive transducers attached over the carotid and femoral arteries.
  • the pulse transit time (PTT) is the time interval (D ⁇ ) between the onset of the carotid and femoral pulse wave upstroke (known as the "foot-to-foot method").
  • the pulse wave travel distance (d), between the carotid and femoral pulse wave recording point, is measured over the body surface with a tape measure.
  • the PWV/PTT values may be obtained from points which are closer together.
  • a problem is the imprecise measurement of the distance between the two pulse wave detections, which is typically measured on the skin.
  • the time interval (D ⁇ ) cannot be determined very well or is not continuous. That leads to an incorrect measurement of the PTT and consequently the PWV.
  • other medical diagnostics based on determining PTT/PWV such as e.g. arterial stiffness measurements or plaque detection, lack precision.
  • Figure 1 shows a first example of a system for determining a pulse wave velocity. It comprises body insertable device 10 in this case in the form of an implantable device, which comprises an actuator 12 for providing a pulse 14 in the vicinity of a vessel wall 16 and a sensor 18 for sensing arrival of the pulse at a different location to the actuator. This may for example be at a location downstream of the actuator 12 having regard to the direction of blood flow, although the sensing may be upstream, or indeed pulse timing measurement may be performed in both opposing directions, as discussed below.
  • a controller 20,22 is provided for controlling the actuator 12 and analyzing the sensor signal.
  • the controller may include some parts which are implanted as part of the device 10, such as control circuitry 20, and some parts 22 which are external to the body insertable device, such as a processor for processing the signals. There is wireless communication 24 between the controller parts.
  • the controller 22, 24 determines a pulse wave velocity from the time difference between actuation of the actuator and sensing of the pulse.
  • Figure 1 shows a cuff-like body insertable device 10 which is positioned around a vessel, in particular an artery 26.
  • the cuff is soft, with a rigidity much lower than the arterial stiffness, and it is wound around the artery.
  • the orientation of the cuff may be dependent on the blood flow direction so that it has to be implanted with the sensor downstream of the actuator with respect to the blood flow direction. Other examples may be insensitive to implantation orientation as described further below.
  • the actuator is for example an electroactive polymer actuator.
  • the sensor may also be implemented as an electroactive polymer pressure or deformation sensor.
  • the actuator and the sensor are clamped either around the whole circumference of the vessel or at one side or edge point.
  • the actuator and sensor may include rigid parts to prevent lift off from the artery when activated. This could be a mass on to which the actuator or sensor is attached, a rigid narrow band around the artery to which the actuator or sensor is attached, or the actuator or sensor themselves may surround the artery.
  • the actuator When the actuator is activated, there is a compression of the artery beneath the actuator, or if the body insertable device is applied within the artery, the actuator may knock against the inner wall of the vessel, or if directed to the blood the actuator may generate the pulse wave directly in the blood. This leads to the generation of an artificial pressure pulse wave in the medium (i.e. blood) in the artery and/or in the artery wall.
  • the medium i.e. blood
  • a piezoelectric or a piezo-resistive pressure sensor may be used.
  • sensors which are sensitive to motion e.g. accelerometer
  • mechanical deflection e.g. strain gauge
  • Other known sensors e.g. MEMS sensor which change in capacitance or other impedance
  • MEMS sensor which change in capacitance or other impedance
  • the device may be used to identify some critical arterial diseases like plaque growth, stenosis and aneurysm.
  • the control circuit 20 for example controls the actuator to deliver a short on/off pulse but in principle also any other pulse shape may be used to control the actuator.
  • the overall controller 20 and 22 is also used to read out and process the sensor signal, to calculate the PTT ap and hence PWV ap values. These calculated values may then be transmitted or stored in a memory for later read out or else the raw data may be provided for external calculation.
  • phase shift between pulse generation and reception may be considered as a possible additional differentiator.
  • connections between the electronics 20 and the sensor and actuator may be realized by electrically isolated flexible wires (or flex-foil) or there may be an electrically isolated part of the cuff itself functioning as the electrical connection lines. There may instead be a cover over the cuff functioning as a connection device to the electronics.
  • the external reading of the data may be achieved by connecting a reading device to it or more conveniently by using state of the art wireless communication principles, which may be an active transceiver device or even more conveniently a passive (inductance coupling based) transceiver.
  • the stiffness of the artery not only has an influence on the PWV ap and PTT ap values but also on the signal amplitude and shape.
  • a soft tissue damps more of the incoming pulse wave than a stiffter tissue. Therefore in addition to the pure time-dependent behaviour, the amplitude and shape of the sensor signal may be taken into account to derive information about the stiffness (and accordingly plaque growth) or other mechanical parameter. It may be desired to calibrate the body insertable device prior to the application. Therefore the pulse wave velocity of the artificially generated pulse may be determined by applying the body insertable device to an artificial tissue (e.g.
  • an artificial artery or even natural artery (human or animal) under conditions similar to the application later.
  • the artery may be filled with blood (or a similar liquid) without generating an active blood flow (to determine the steady state PWV ap /PTT ap ) and/or at different blood flow velocities and/or different blood pressures.
  • this calibration may include tests with different stiffness values or added material (representing artificial plaque) to the tissue (e.g. artificial artery) to know the change of PWV ap and PTT ap values prior to the application as precisely as possible.
  • This calibration also enables the determination of the (absolute) blood flow velocity.
  • the time interval D ⁇ i is determined by the device. However, this time interval is based on the superposition of the pulse wave velocity of the artificial pulse and the blood flow velocity, which will be assumed to be in the same direction. Therefore it is necessary to separate the blood flow velocity from the artificial pulse wave velocity. Although it can be assumed that the artificially generated pulse wave propagates much faster than the velocity of the blood flow (and thus the influence of the blood flow may be negligible), it may be of additional benefit to determine the real blood flow velocity based on this calibration.
  • V bf is the velocity of the blood flow and v ap is the artificial pulse velocity, Ad being the distance between pulse generation and reception and Ati the measured time interval.
  • the propagation velocity of the artificial pulse wave is known, the time interval Ati is measured and the distance Ad is known prior to the application. Accordingly the blood flow velocity can be calculated.
  • the artificial pulse may travel also along the arterial wall.
  • This propagation path may be considered for example when aneurysms need to be detected, since in such case the propagation path certainly will change.
  • Figure 3 shows an arrangement for this purpose.
  • the actuator 12 and sensor 18 are provided along a direct path along the vessel wall.
  • the actuator knocks on the outer vessel wall such that a pulse wave preferably propagates on and through the vessel wall.
  • a pulse wave preferably propagates on and through the vessel wall.
  • the wall-stiffness e.g. plaque
  • the wall configuration e.g. aneurism
  • Figure 4 shows an example in which the actuator 12 is part of a first body insertable device lOa and the sensor 18 is part of a second body insertable device lOb.
  • the actuator and the sensor may then be spatially separated and not part of the same body insertable device. Accordingly the impact of the body insertable device itself (e.g. cuff) on the variation in stiffness of the artery may be reduced but also larger distances may be covered.
  • the actuator and sensor may be connected to the same electronics or they may have their own circuits 20a, 20b as shown.
  • Figure 5 shows a modification in which there is an actuator and a sensor at each end of the body insertable device.
  • a first advantage of this configuration is the detection of the natural pulse wave (originated from the heart).
  • This natural pulse wave will first initiate a sensor signal at sensor 18' followed by the generation of a signal at sensor 18, even without any artificial pulse generation. Accordingly the calculated time interval would then correspond to the PWV initiated by the heart. This may be determined in parallel to the arbitrarily generated pulse wave velocity, since the natural pulse wave and arbitrary one may differ in their form shape, by driving the actuator with a pre-defmed driving form.
  • a first time interval Ati may be determined by actuating the actuator 12 and sensing with sensor 18. Then a second time interval D ⁇ 2 is determined by actuating the second actuator 12' and sensing with the second sensor 18'.
  • a new time interval which is the difference between the two measured values can be defined:
  • an EAP device can be used as actuator and sensor, even in parallel.
  • a high frequency oscillating signal may be provided and impedance measurement of the EAP can be determined. This impedance varies with applied mechanical load, or pressure or (change of) other environmental conditions.
  • one or more multipurpose EAP generators may be used, for example one at each end of the body insertable device, able to generate a pressure pulse and to measure a change in pressure.
  • the multipurpose EAP generator can also be used as a parallel actuator, as described above.
  • the actuator can be configured to partially close the vessel during blood flow or PWV measurements as shown in Figure 6.
  • Figure 6 shows two levels of vessel blockage controlled by the actuator 12 and this may be achieved by applying a DC actuation voltage over which the measurement actuation (AC voltage) is superimposed.
  • AC voltage measurement actuation
  • the vessel can be fully blocked by the EAP generator element to avoid interference of the heart beat with the measurement, because the (elastic) movement of the vessel walls due to the heart beat pulse is shut off for the time of the measurement.
  • the vessel can be partially blocked by actuating the EAP generator. This enables a series of measurements at different actuation levels, simulating a (partial) blockage. A series of measurements under different known conditions can increase the accuracy of the blood flow measurement and also aid in stenosis detection.
  • the measured blood flow will only significantly change if the partial closure of the vessel by the actuator is more than a stenosis (in the vicinity of the actuator).
  • the method may be applied to many applications. Of main interest is personal health devices. Although the application described above is focussing on the detection of natural plaque (growth), other applications may be possible as well. Additional applications are the possible detection of plaque growth initiated by implanted other devices such as e.g. a by-pass. Often these types of artificial devices can induce plaque followed by clogging. Yet another possible application would be to detect the development and growth of aneurisms.
  • a controller performs the data processing.
  • the controller can be implemented in numerous ways, with software and/or hardware, to perform the various functions required.
  • a processor is one example of a controller which employs one or more microprocessors that may be programmed using software (e.g., microcode) to perform the required functions.
  • a controller may however be implemented with or without employing a processor, and also may be implemented as a combination of dedicated hardware to perform some functions and a processor (e.g., one or more programmed microprocessors and associated circuitry) to perform other functions.
  • controller components that may be employed in various embodiments of the present disclosure include, but are not limited to, conventional microprocessors, application specific integrated circuits (ASICs), and field-programmable gate arrays
  • a processor or controller may be associated with one or more storage media such as volatile and non-volatile computer memory such as RAM, PROM, EPROM, and EEPROM.
  • the storage media may be encoded with one or more programs that, when executed on one or more processors and/or controllers, perform the required functions.
  • Various storage media may be fixed within a processor or controller or may be transportable, such that the one or more programs stored thereon can be loaded into a processor or controller.
  • EAP electroactive polymer
  • EAPs are an emerging class of materials within the field of electrically responsive materials. EAPs can work as sensors or actuators and can easily be manufactured into various shapes allowing easy integration into a large variety of systems.
  • EAPs include low power, small form factor, flexibility, noiseless operation, accuracy, the possibility of high resolution, fast response times, and cyclic actuation.
  • EAP material give rise to applicability to new applications.
  • An EAP device can be used in any application in which a small amount of movement of a component or feature is desired, based on electric actuation. Similarly, the technology can be used for sensing small movements.
  • EAPs enable functions which were not possible before, or offers a big advantage over common sensor / actuator solutions, due to the combination of a relatively large deformation and force in a small volume or thin form factor, compared to common actuators.
  • EAPs also give noiseless operation, accurate electronic control, fast response, and a large range of possible actuation frequencies, such as 0 - lMHz, most typically below 20 kHz.
  • Devices using electroactive polymers can be subdivided into field-driven and ionic- driven materials.
  • Examples of field-driven EAPs include Piezoelectric polymers, Electrostrictive polymers (such as PVDF based relaxor polymers) and Dielectric Elastomers.
  • Other examples include Electrostrictive Graft polymers, Electrostrictive paper, Electrets, Electroviscoelastic Elastomers and Liquid Crystal Elastomers.
  • ionic-driven EAPs are conjugated/conducting polymers, Ionic Polymer Metal Composites (IPMC) and carbon nanotubes (CNTs).
  • IPMC Ionic Polymer Metal Composites
  • CNTs carbon nanotubes
  • Other examples include ionic polymer gels.
  • Field-driven EAPs are actuated by an electric field through direct electromechanical coupling. They usually require high fields (tens of megavolts per meter) but low currents. Polymer layers are usually thin to keep the driving voltage as low as possible.
  • Ionic EAPs are activated by an electrically induced transport of ions and/or solvent. They usually require low voltages but high currents. They require a liquid/gel electrolyte medium (although some material systems can also operate using solid electrolytes).
  • a first notable subclass of field driven EAPs are Piezoelectric and Electrostrictive polymers. While the electromechanical performance of traditional piezoelectric polymers is limited, a breakthrough in improving this performance has led to PVDF relaxor polymers, which show spontaneous electric polarization (field driven alignment). These materials can be pre-strained for improved performance in the strained direction (pre-strain leads to better molecular alignment). Normally, metal electrodes are used since strains usually are in the moderate regime (1-5%). Other types of electrodes (such as conducting polymers, carbon black based oils, gels or elastomers, etc.) can also be used. The electrodes can be continuous, or segmented.
  • Dielectric Elastomers Another subclass of interest of field driven EAPs is that of Dielectric Elastomers.
  • a thin film of this material may be sandwiched between compliant electrodes, forming a parallel plate capacitor.
  • the Maxwell stress induced by the applied electric field results in a stress on the film, causing it to contract in thickness and expand in area.
  • Strain performance is typically enlarged by pre-straining the elastomer (requiring a frame to hold the pre-strain). Strains can be considerable (10-300%).
  • the electrodes can be continuous, or segmented.
  • IPMCs Ionic Polymer Metal Composites
  • Typical electrode materials are Pt, Gd, CNTs, CPs, Pd.
  • Typical electrolytes are Li+ and Na+ water-based solutions.
  • cations typically travel to the cathode side together with water. This leads to reorganization of hydrophilic clusters and to polymer expansion. Strain in the cathode area leads to stress in rest of the polymer matrix resulting in bending towards the anode. Reversing the applied voltage inverts bending.
  • Well known polymer membranes are Nafion® and Flemion®.
  • conjugated/conducting polymers Another notable subclass of Ionic polymers is conjugated/conducting polymers.
  • a conjugated polymer actuator typically consists of an electrolyte sandwiched by two layers of the conjugated polymer. The electrolyte is used to change oxidation state. When a potential is applied to the polymer through the electrolyte, electrons are added to or removed from the polymer, driving oxidation and reduction. Reduction results in contraction, oxidation in expansion.
  • the electrolyte can be a liquid, a gel or a solid material (i.e. complex of high molecular weight polymers and metal salts).
  • Most common conjugated polymers are polypyrrole (PPy), Polyaniline (PANi) and polythiophene (PTh).
  • An actuator may also be formed of carbon nanotubes (CNTs), suspended in an electrolyte.
  • CNTs carbon nanotubes
  • the electrolyte forms a double layer with the nanotubes, allowing injection of charges. This double-layer charge injection is considered as the primary mechanism in CNT actuators.
  • the CNT acts as an electrode capacitor with charge injected into the CNT, which is then balanced by an electrical double-layer formed by movement of electrolytes to the CNT surface. Changing the charge on the carbon atoms results in changes of C-C bond length. As a result, expansion and contraction of single CNT can be observed.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
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  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)

Abstract

L'invention concerne un système pour déterminer une vitesse d'onde pulsatile comprenant un dispositif insérable dans une lumière corporelle pourvu d'un actionneur pour fournir une impulsion au voisinage d'une paroi de vaisseau et un capteur pour détecter l'arrivée de l'impulsion. Une vitesse d'onde pulsatile est obtenue à partir de la différence de temps entre l'actionnement de l'actionneur et la détection de l'impulsion. Ce système est utilisé pour créer une impulsion artificielle qui est transmise le long d'un vaisseau sur une distance connue avant la détection par un capteur.
PCT/EP2018/082216 2017-11-22 2018-11-22 Détermination de vitesse d'onde pulsatile Ceased WO2019101855A1 (fr)

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Application Number Priority Date Filing Date Title
CN201880075939.0A CN111372512A (zh) 2017-11-22 2018-11-22 脉搏波速度确定
EP18804010.9A EP3713483B1 (fr) 2017-11-22 2018-11-22 Détermination de la vitesse des ondes d'impulsion
US16/766,078 US20200345246A1 (en) 2017-11-22 2018-11-22 Pulse wave velocity determination
JP2020528135A JP2021504000A (ja) 2017-11-22 2018-11-22 脈波伝播速度の決定

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EP17202984.5A EP3488775A1 (fr) 2017-11-22 2017-11-22 Détermination de la vitesse des ondes d'impulsion
EP17202984.5 2017-11-22

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US20220054029A1 (en) * 2018-12-17 2022-02-24 Foundry Innovation & Research 1, Ltd. Pulse Wave Velocity Measurement
JP2023526673A (ja) * 2020-05-19 2023-06-22 コラヴィ メディカル，インコーポレーテッド 注射可能な血行動態監視デバイス、システム、及び方法
US12268493B2 (en) 2016-08-11 2025-04-08 Foundry Innovation & Research 1, Ltd. Systems and methods for self-directed patient fluid management
US12310707B2 (en) 2016-08-11 2025-05-27 Foundry Innovation & Research 1, Ltd. Wireless resonant circuit and variable inductance vascular monitoring implants and anchoring structures therefore
US12465324B2 (en) 2015-02-12 2025-11-11 Foundry Innovation & Research 1, Ltd. Patient fluid management systems and methods employing integrated fluid status sensing
US12465233B2 (en) 2022-07-29 2025-11-11 Foundry Innovation & Research 1, Ltd. Multistranded conductors adapted to dynamic in vivo environments

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CZ309588B6 (cs) * 2021-07-30 2023-05-03 Univerzita Hradec Králové Způsob sledování pohybu plodu a zařízení pro sledování pohybu plodu
CN118252483A (zh) * 2024-03-29 2024-06-28 广州珠江健康资源管理集团有限公司 一种主动脉式脉搏波传导速度测量装置及测量方法

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Publication number Priority date Publication date Assignee Title
US12465324B2 (en) 2015-02-12 2025-11-11 Foundry Innovation & Research 1, Ltd. Patient fluid management systems and methods employing integrated fluid status sensing
US12268493B2 (en) 2016-08-11 2025-04-08 Foundry Innovation & Research 1, Ltd. Systems and methods for self-directed patient fluid management
US12310707B2 (en) 2016-08-11 2025-05-27 Foundry Innovation & Research 1, Ltd. Wireless resonant circuit and variable inductance vascular monitoring implants and anchoring structures therefore
US20220054029A1 (en) * 2018-12-17 2022-02-24 Foundry Innovation & Research 1, Ltd. Pulse Wave Velocity Measurement
JP2023526673A (ja) * 2020-05-19 2023-06-22 コラヴィ メディカル，インコーポレーテッド 注射可能な血行動態監視デバイス、システム、及び方法
US12465233B2 (en) 2022-07-29 2025-11-11 Foundry Innovation & Research 1, Ltd. Multistranded conductors adapted to dynamic in vivo environments

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EP3713483B1 (fr) 2022-01-05
JP2021504000A (ja) 2021-02-15
US20200345246A1 (en) 2020-11-05
EP3488775A1 (fr) 2019-05-29
EP3713483A1 (fr) 2020-09-30

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